How much can one applicant receive?

$0 – $900,000 per recipient. The source states: “Award floor is $0; Award ceiling is $900,000 per application.”.

When is the application deadline?

May 16, 2028. Response date as listed on grants.gov

Is matching funding required?

No. The source states that no matching funds are required. Cost sharing is not required (false).

OtherOpenFixedDepartment of Health and Human Services - FDA

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Awards $0 – $900,000 per recipient for city or township governments, county governments, faith-based or community-based organizations, federal governments, for-profit organizations (other than small businesses), for-profit organizations - small businesses, foreign organizations, higher education institutions - private, higher education institutions - public/state controlled, independent school districts, indian/native american tribal governments - federally recognized, indian/native american tribal governments - other than federally recognized, local governments, native american tribal organizations, nonprofits other than institutions of higher education, nonprofits with 501(c)(3) irs status, nonprofits without 501(c)(3) irs status, other legal entity, public housing authorities/indian housing authorities, regional organizations, special district governments, state governments, u.s. territory or possession, closing May 16, 2028.

Official page

City or Township GovernmentsCounty GovernmentsFaith-based or Community-based OrganizationsFederal GovernmentsFor-Profit Organizations (Other than Small Businesses)For-Profit Organizations - Small BusinessesForeign OrganizationsHigher Education Institutions - PrivateHigher Education Institutions - Public/State ControlledIndependent School DistrictsIndian/Native American Tribal Governments - Federally RecognizedIndian/Native American Tribal Governments - Other than Federally RecognizedLocal GovernmentsNative American Tribal OrganizationsNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS StatusNonprofits without 501(c)(3) IRS StatusOther Legal EntityPublic Housing Authorities/Indian Housing AuthoritiesRegional OrganizationsSpecial District GovernmentsState GovernmentsU.S. Territory or Possession Agriculture Consumer Protection Food and Nutrition

In one sentence

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) awards $0 – $900,000 per recipient, open to city or township governments, county governments, faith-based or community-based organizations, federal governments,…

Record fields

Program pool (total): Not confirmed
Total across all awards in this programme. Not an amount any single applicant can receive.
Award ceiling (per project): $900,000
Award floor is $0; Award ceiling is $900,000 per application.
Award floor: $0
Typical award: Not confirmed
Deadline: May 16, 2028
Deadline type: fixed
Opens: Jul 11, 2025
Status: Open
Eligible entities: City or Township Governments · County Governments · Faith-based or Community-based Organizations · Federal Governments · For-Profit Organizations (Other than Small Businesses) · For-Profit Organizations - Small Businesses · Foreign Organizations · Higher Education Institutions - Private · Higher Education Institutions - Public/State Controlled · Independent School Districts · Indian/Native American Tribal Governments - Federally Recognized · Indian/Native American Tribal Governments - Other than Federally Recognized · Local Governments · Native American Tribal Organizations · Nonprofits Other Than Institutions of Higher Education · Nonprofits with 501(c)(3) IRS Status · Nonprofits without 501(c)(3) IRS Status · Other Legal Entity · Public Housing Authorities/Indian Housing Authorities · Regional Organizations · Special District Governments · State Governments · U.S. Territory or Possession
Geography: Not stated
Matching funds: No
Disbursement: Not confirmed
Application effort: Not confirmed
Currency: USD

How much money is available?

Two different figures govern a programme and they are not interchangeable. The programme pool is what the funder has allocated across every award it will make this cycle. The award ceiling is the most one applicant can be granted.

Program pool (total)Across all awards this cycle

Not stated

Award ceiling (per project)The most one applicant can receive

$900,000

Source wording: “Award floor is $0; Award ceiling is $900,000 per application.”

Who can apply?

entity

City or Township Governments, County Governments, Faith-based or Community-based Organizations, Federal Governments, For-Profit Organizations (Other than Small Businesses), For-Profit Organizations - Small Businesses, Foreign Organizations, Higher Education Institutions - Private, Higher Education Institutions - Public/State Controlled, Independent School Districts, Indian/Native American Tribal Governments - Federally Recognized, Indian/Native American Tribal Governments - Other than Federally Recognized, Local Governments, Native American Tribal Organizations, Nonprofits Other Than Institutions of Higher Education, Nonprofits with 501(c)(3) IRS Status, Nonprofits without 501(c)(3) IRS Status, Other Legal Entity, Public Housing Authorities/Indian Housing Authorities, Regional Organizations, Special District Governments, State Governments, U.S. Territory or Possession

Source field: entity types

industry

Agriculture, Consumer Protection, Food and Nutrition

Source field: industries

use

Addressing unmet needs in rare diseases or conditions, Clinical trials of products, Collaborative clinical trials, Efficient clinical trials, Evaluating efficacy and/or safety, Innovative clinical trials, Support for new indication or change in labeling

Source field: use of funds

size limit

Not stated

Source field: applicant size limit

clause text

Non-domestic (non-U.S.) entities and foreign components are eligible. See grants.gov for complete eligibility details.

We store the structured fields above. Clause-by-clause text from the guidelines is not connected for this record.

When does it close?

May 16, 2028623 daysfixed deadline

Response date as listed on grants.gov

What can the money be used for?

Clinical trials of productsEvaluating efficacy and/or safetySupport for new indication or change in labelingAddressing unmet needs in rare diseases or conditionsCollaborative clinical trialsEfficient clinical trialsInnovative clinical trials

These categories come from the source's own classification. A line-item cost table, where the programme publishes one, lives in the guidelines and is not parsed for this record.

How hard is the application?

Application effort: Not confirmed
Disbursement: Not confirmed
Matching funds: No
Cost sharing is not required (false).

Who has received this funding?

No award records yet

We hold no prior awards for this programme. That is a gap in what we have connected, not a finding that the programme has never funded anyone — check the official page, which may list past recipients.

Common questions

Every answer below is a stored field from this record. Questions the source did not answer are not asked.

How much can one applicant receive?: $0 – $900,000 per recipient. The source states: “Award floor is $0; Award ceiling is $900,000 per application.”.
When is the application deadline?: May 16, 2028. Response date as listed on grants.gov
Who is eligible to apply?: City or Township Governments, County Governments, Faith-based or Community-based Organizations, Federal Governments, For-Profit Organizations (Other than Small Businesses), For-Profit Organizations - Small Businesses, Foreign Organizations, Higher Education Institutions - Private, Higher Education Institutions - Public/State Controlled, Independent School Districts, Indian/Native American Tribal Governments - Federally Recognized, Indian/Native American Tribal Governments - Other than Federally Recognized, Local Governments, Native American Tribal Organizations, Nonprofits Other Than Institutions of Higher Education, Nonprofits with 501(c)(3) IRS Status, Nonprofits without 501(c)(3) IRS Status, Other Legal Entity, Public Housing Authorities/Indian Housing Authorities, Regional Organizations, Special District Governments, State Governments, U.S. Territory or Possession.
What can the funding be used for?: Clinical trials of products, Evaluating efficacy and/or safety, Support for new indication or change in labeling, Addressing unmet needs in rare diseases or conditions, Collaborative clinical trials, Efficient clinical trials, Innovative clinical trials, as classified by the source.
Is matching funding required?: No. The source states that no matching funds are required. Cost sharing is not required (false).

Provenance

Source pagegrants.gov

Retrieved2026-09-01

MethodAutomated check

First seen2026-09-01

The official page governs. If the source and this record disagree, the source is correct — programmes change their terms between our checks, so confirm every figure above before you apply.